Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

Total Sleep Time, Per Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]

All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

Total Sleep Time, Per Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]

All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

Total Sleep Time, Per Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]

All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.

Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.

Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.

Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2). [ Time Frame: Nights 1-2 ] [ Designated as safety issue: No ]

Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.

Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16). [ Time Frame: Nights 15-16 ] [ Designated as safety issue: No ]

Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.

Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30). [ Time Frame: Nights 29-30 ] [ Designated as safety issue: No ]

Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.

Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.

Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.

Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.

The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting.

A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study.

Has a body mass index between 18 and 34, inclusive.

Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:

The predominant complaint is difficulty initiating or maintaining sleep, or non-restorative sleep, for at least 3 months.

The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.

The sleep disturbance does not occur exclusively during the course of narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or parasomnia.

The disturbance does not occur exclusively during the course of another mental disorder (eg, major depressive disorder, generalized anxiety disorder, delirium).

The disturbance is not due to the direct physiological effects of a substance or a general medical condition.

Based on sleep history, the subject reports a history of subjective sleep latency ≥45 minutes and a subjective total sleep time ≤6.5 hours for at least 3 months.

Based on sleep history, the subject's habitual bedtime is between 10:00 PM and 1:00 AM.

On at least 3 of the first 5 nights of single blind run-in placebo treatment, the subject must have an subjective sleep latency of ≥45 minutes and a subjective total sleep time of <6.5 hours.

The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in must be ≤30 minutes.

The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in must be ≤30 minutes.

The difference of the average subjective sleep latency from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in must be ≤30 minutes.

Is willing to have a fixed bedtime and agrees to go to bed within ± 30 minutes of the habitual bedtime during the entire study, exceptions will be allowed at weekends that are not within 2 days of a polysomnography visit.

Has consistent access to a touch-tone phone and is willing to complete all telephone questionnaires within 60 minutes of wake time each morning throughout the entire duration of the study.

Is willing to remain in bed for at least 6.5 hours each night during the entire study.

Based on sleep history, the subject normally uses pharmacologic assistance to sleep 0 to 4 (maximum allowable) times per week in the last 3 months. Subjects must agree to discontinue the use of all sleep aids beginning 1 week prior to the first dose of single-blind study medication and throughout the entire duration of the study.

The subject must complete the post-sleep questionnaire morning questionnaire on at least 5 of 7 mornings for all 3 weeks of single-blind run-in.

Has a mean latency to persistent sleep of ≥20 minutes on 2 consecutive screening nights, with neither night less than 15 minutes, via polysomnography screening assessment during the single-blind placebo run-in period.

Exclusion Criteria:

Has a known hypersensitivity to ramelteon or related compounds, including melatonin.

Has participated in a study involving ramelteon within 6 months of initial Screening Visit.

Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first night of single-blind study medication.

Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or has flown across greater than 3 time zones within 7 days prior to Screening.

Has participated in a weight loss program or has substantially altered his or her exercise routine within 30 days prior to the first night of single-blind study medication.

Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months.

Has a history of drug addiction or alcohol abuse and/or regularly consumes 4 or more alcoholic drinks per day within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.

Has a current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single blind study medication.

The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

Has a positive urine drug screen for an illegal substance at the initial Screening Visit.

Has a positive urine drug screen at polysomnography screening or a positive alcohol breathalyzer test at polysomnography screening or randomization.

Exhibits a placebo response during the single-blind placebo run-in period. A placebo response is defined as having:

a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the first week of single-blind run-in.

a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the second week of single-blind run-in.

a difference in average subjective sleep latency >30 minutes from first 3 nights of data in the first week of single-blind run-in to the average of the last 3 nights of data in the third week of single-blind run-in.

Has periodic leg movements during sleep with arousal index (per hour of sleep) >10 as seen on polysomnography on the first night of polysomnography screening.

Has any additional condition(s) that in the Investigator's opinion would:

Affect sleep/wake function

Prohibit the subject from completing the study

Not be in the best interest of the subject to complete the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756002